Recruiting

CGM for Management of Type 2 Diabetes in Pregnancy

ClinicalTrials.gov IDNCT06628453

PhaseNA

Enrollment564

SponsorUniversity of Alabama at Birmingham

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Type 2 Diabetes Mellitus (T2DM), Pregnancy

About this study

The goal of this clinical trial is to learn if continuous glucose monitoring works better than self-monitoring of blood glucose (fingersticks) to treat type 2 diabetes in pregnancy. It will also learn about all risk factors (biologic, personal, social) for maternal and infant complications in type 2 diabetes pregnancies. The main questions it aims to answer are: 1. Does continuous glucose monitoring improve infant outcomes compared to self-monitoring of blood glucose? 2. Does continuous glucose monitoring improve maternal diabetes control and other maternal outcomes compared to self-monitoring of blood glucose? 3. What other factors increase the risk of maternal and infant complications? Participants will: 1. Use continuous glucose monitoring or self-monitoring of blood glucose to monitor blood sugar control from enrollment until delivery 2. Have blood drawn at enrollment, 24 weeks, 34 weeks and delivery to measure hemoglobin A1c levels and store blood for future analysis 3. Complete surveys about social support, environmental stressors, diabetes distress and glucose monitoring satisfaction at research visits 4. Have umbilical cord blood collected at delivery for analysis

Interventions

Device: CGM — Real-time continuous glucose monitoring

Primary outcomes

Time in Range (TIR) at 34 weeks gestation (33 to 35 weeks gestation)
Composite Neonatal Morbidity (From the date of delivery to the date of neonatal hospital discharge, assessed up to 12 months of life)

Eligibility information

Inclusion Criteria: * Type 2 diabetes mellitus treated with daily insulin injections or oral hypoglycemic agents diagnosed before pregnancy or at less than 14 weeks gestation with hemoglobin A1c 6.5% or greater * Pregnant with viable fetus at 6 to less than 23 weeks gestation * Maternal age 18-50 years old Exclusion Criteria: * Unable or unwilling to wear CGM due to intolerance to medical-grade adhesives or skin conditions * Multiple gestation * Major fetal anomaly or two or more minor fetal anomalies * Planned delivery outside study consortium * Participating in another conflicting interventional study * Participation in this trial in a previous pregnancy * Patient unable to consent * Physician refusal for other reasons

Study locations

University of Alabama at Birmingham, Birmingham, Alabama 35233 United States
University of California at San Diego, San Diego, California 92121 United States
University of North Carolina - Chapel Hill, Chapel Hill, North Carolina 27599 United States
Oregon Health and Science University, Portland, Oregon 97213 United States
University of Pennsylvania, Philadelphia, Pennsylvania 19104 United States
Prisma Health Greenville Memorial Hospital, Greenville, South Carolina 29605 United States
University of Texas Health Science Center at Houston, Houston, Texas 77030 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.